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Here’s the latest:
British health officials have issued a warning about Pfizer’s coronavirus vaccine, saying that it should not be given to people “with a history of significant allergic reaction.”
The advisory comes after two members of Britain’s National Health Service suffered symptoms of “anaphylactoid reaction” after they received the shots on Tuesday, the first day of mass vaccinations in the United Kingdom.
Both are said to be recovering, according to the Guardian.
In response to the adverse reactions, the British regulatory agency issued the following advisory:
“Any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline autoinjector) should not receive the Pfizer/BioNtech vaccine. Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.”
The U.K. is the first country to approve and rollout the Pfizer vaccine, which has been shown to be 90% effective in preventing illness from COVID-19.
U.S. regulators are expected to meet Thursday to decide whether to grant the vaccine emergency authorization.
Pfizer and its German partner BioNTech are assisting British health officials with an investigation, but have maintained that the vaccine is proven to be safe, according to the Wall Street Journal.
A Federal Drug Administration briefing said that only slightly more people in the trials had an allergic reaction to the vaccine compared to those who took a placebo: around 0.6% on the vaccine versus 0.5% on the placebo.
Professor Stephen Powis, medical director for the NHS in England, called allergic reactions “common with new vaccines.”
But Dr. Eric Topol, a professor of molecular medicine at Scripps Research, noted that clinical trials “are not the real world of people” and that those with severe allergies were excluded from the Pfizer study.
“There will be more safety issues ahead,” Topol warned.
Clinical trials are not the real world of people; they all have inclusion/exclusion criteria.
Like no history of anaphylaxis (protocol👇).
The same day @Pfizer vaccine rolled out, 2 cases of severe allergic reactions in healthcare workers.
There will be more safety issues ahead. pic.twitter.com/9SRrWyPPDu
— Eric Topol (@EricTopol) December 9, 2020